Comparison of Regional Citrate Anticoagulation (RCA) and Regional Anticoagulation by Citrate-Free Decalcification in Renal (RACD) Replacement Therapy Using Sustained Low-Efficiency Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Measurement of the plasma urea
研究概览
简要总结
One of the main RRT issues is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate Anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol / L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic flow of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aim to compare intermittent RRT using 4% Citrate infusion and without Citrate.
详细描述
Background: Renal Replacement Therapy (RRT), requires anticoagulation of the extracorporal circuit (ECC) using heparin, citrate or repeated rinsing. Difficulties of implementation or exposition to complications (thrombosis, hemorrhage or electrolyte disorder) are frequent.
Purpose: Regional anticoagulation of the ECC based on ionized calcemia reduction, as using citrate, but induced by the use of a calcium-free dialysate associated with the performance of the hemofilter could reduce these risks and the cost of intermittent RRT. This study aims to compare the efficiency of a regional anticoagulation technique based on the reduction of Ionized Calcium in the extracorporal circuit, without the use of Citrate and with Citrate during intermittent RRT.
Abstract: One of the main RRT issue is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol/L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic passage of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aims at comparing intermittent RRT using 4% Citrate infusion and without Citrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patient requiring Renal replacement Therapy
排除标准
- •Age < 18 years
- •Pregnancy
- •Hypercalcemia ≥ 3 mmol/L.
- •Major under guardianship
- •Major deprived of freedom
- •Impossible to obtain free and informed consent
- •Presence of hemostasis or coagulation disorders:
- •Thrombocytopenia < 30 G/L.
- •Curative anticoagulation.
- •Severe liver disease with Prothrombin rate <30%.
- •Coagulation factor deficit.
- •Not registered to a social security system.
结局指标
主要结局
Measurement of the plasma urea
时间窗: up to 8 hours
We will compare plasma urea clearance after reaching the prescribed session time without irreversible coagulation of the extracorporeal circuit, with both methods tested in the study.
次要结局
- Number of catheter thrombosis during each RRT session(Hour 0; 480 minutes)
- Measurement of the concentration of Ca²+i (patient)(30minutes, 1 hour; 4 hours and 8 hours)
- Measurement of the concentration of Ca²+i in post-filter(30 minutes, 1 hour; 4 hours and 8 hours)
- Measurement of the concentration of Mg2+(8 hours)
- Measurement of blood pressure(Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes)
- Number of circuit losses during each RRT session,(Hour 0; 480 minutes)
- Measurement of heart rate during each RRT session.(Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes)